Spots Global Cancer Trial Database for Fluorescent Imaging of Nerves With Illuminare-1 During Surgery
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Trial Identification
Brief Title: Fluorescent Imaging of Nerves With Illuminare-1 During Surgery
Official Title: Phase I Trial of Real-Time Intraoperative Fluorescent Imaging of Nerve Structures Using Illuminare-1, A Novel Myelin-Binding Fluorophore
Study ID: NCT04983862
Conditions
Study Description
Brief Summary: This study will test the safety of using Illuminare-1 during standard surgery for prostate cancer. The study researchers will test increasing doses of Illuminare-1 to find the dose that makes the nerve structures fluoresce (light up) but causes few or mild side effects. When the researchers find this dose, it will be tested in new groups of study participants to see whether surgery performed using Illuminare-1 guidance is better than surgery performed without intraoperative guidance. The researchers will also do tests to study the way the body absorbs, distributes, and gets rid of Illuminare-1. This study is the first to test Illuminare-1 in people. Illuminare-1 has received Fast Track designation from the US FDA.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities), Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited protocol activities), Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Contact Details
Name: Timothy Donahue, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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